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Primary:
Secondary:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Administration of Insulin Glargine and Sulfonylurea or Metformin |
|
| 2 | Active Comparator | Administration of Sulfonylurea or Metformin + a second Oral Anti Diabetic (OAD) among Glyburide, Glyclazide,Glimiperide,Glipizide or Metformin |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Insulin Glargine | Drug | Throughout study period |
| |
| Glyburide |
| Measure | Description | Time Frame |
|---|---|---|
| A1c values | At baseline and 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events including hypoglycemia | From the beginning to the end of the study |
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Inclusion Criteria:
Exclusion Criteria:
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
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| Name | Affiliation | Role |
|---|---|---|
| Bruno Jolain | Sanofi | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sanofi-Aventis | Beijing | China |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D000069036 | Insulin Glargine |
| D005905 | Glyburide |
| D005907 | Gliclazide |
| D005913 | Glipizide |
| D008687 | Metformin |
| ID | Term |
|---|---|
| D049528 | Insulin, Long-Acting |
| D061385 | Insulins |
| D010187 | Pancreatic Hormones |
| D036361 | Peptide Hormones |
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| Drug |
Combination throughout the study period. Titrate to FPG ≤ 100 mg/dl. |
|
| Glyclazide | Drug | Combination throughout the study period. Titrate to FPG ≤ 100 mg/dl. |
|
| Glimiperide | Drug | Combination throughout the study period. Titrate to FPG ≤ 100 mg/dl. |
|
| Glipizide | Drug | Combination throughout the study period. Titrate to FPG ≤ 100 mg/dl. |
|
| Metformin | Drug | Combination throughout the study period. Titrate to FPG ≤ 100 mg/dl. |
|
| D004700 | Endocrine System Diseases |
| D006728 |
| Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D013453 | Sulfonylurea Compounds |
| D014508 | Urea |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D000096926 | Benzenesulfonamides |
| D013449 | Sulfonamides |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |